CHAPTER 15
CORRECTIONAL FACILITY PHARMACY PRACTICE
657—15.1(155A) Purpose and scope. It is the intent of these rules to authorize the department of corrections to distribute prescription drugs to inmates in correctional institutions by and through a network of pharmacies located in facilities operated pursuant to Iowa Code chapter 246. The pharmacies shall be licensed by the board with limited-use pharmacy licenses designated as correctional facility pharmacy licenses and shall be located in facilities operated pursuant to Iowa Code chapter 246. Pharmacists shall be responsible for any delegated act performed by supportive personnel under their supervision. The requirements of these rules for correctional facility pharmacy practice are in addition to the requirements of 657—Chapter 8 and other rules of the board relating to the services provided by the pharmacies.
657—15.2(126,155A) Definitions. For purposes of this chapter, the following definitions shall apply:
“Board” means the Iowa board of pharmacy examiners.
“Department” means the Iowa department of corrections.
“Medication prescription order” means an order for a drug or device for a person in custody status in a correctional institution, originated by a practitioner authorized to prescribe, and which meets the information requirements for a prescription order but is recorded, distributed, and administered as though it were a medication order.
“Provisional stock” means a limited inventory of drugs stored outside the confines of the correctional facility pharmacy and accessible to designated health services staff for the purpose of initiating emergency or first-dose medication prescription orders issued during periods when the pharmacist is unavailable.
657—15.3(155A) Pharmacist in charge. One professionally competent, legally qualified pharmacist in charge in each pharmacy shall be responsible for, at a minimum, the following:
	1.	Ensuring that the pharmacy utilizes an ongoing, systematic program for achieving performance improvement and ensuring the quality of pharmaceutical services;
	2.	Ensuring that the pharmacy employs an adequate number of qualified personnel commensurate with the size and scope of services provided by the pharmacy;
	3.	Ensuring that a quarterly inspection of all pharmaceuticals located at the correctional facility including emergency and provisional stocks located outside the confines of the pharmacy is completed and documented;
	4.	Ensuring the availability of any equipment and references necessary for the particular practice of pharmacy;
	5.	Preparing a written operations manual governing pharmacy functions; periodically reviewing and revising those policies and procedures to reflect changes in processes, organization, and other pharmacy functions; ensuring that policies and procedures are consistent with board rules and the policies and rules of the department relating to pharmaceutical services; and ensuring that all pharmacy personnel are familiar with the contents of the manual;
	6.	Ensuring that a pharmacist performs prospective drug use reviews as specified in rule 657—8.21(155A);
	7.	Ensuring that a pharmacist provides drug information to other health professionals, to other caregivers, and to patients as required or requested;
	8.	Dispensing drugs to patients, including the packaging, preparation, compounding, and labeling functions performed by pharmacy personnel;
	9.	Delivering drugs to the patient or the patient’s agent;
	10.	Ensuring that patient medication records are maintained as specified in rule 15.8(124,126,155A);
	11.	Training pharmacy technicians and supportive personnel;
	12.	Establishing policies for the procurement and storage of prescription drugs and devices and other products dispensed from the pharmacy;
	13.	Disposing of and distributing drugs from the pharmacy;
	14.	Maintaining records of all transactions of the pharmacy necessary to maintain accurate control over and accountability for all drugs as required by applicable state and federal laws, rules, and regulations;
	15.	Establishing and maintaining effective controls against the theft or diversion of prescription drugs and records for such drugs;
	16.	Ensuring the legal operation of the pharmacy, including meeting all inspection and other requirements of state and federal laws, rules, and regulations governing the practice of pharmacy.
657—15.4(155A) Reference library. References may be printed or computer-accessed. Each correctional facility pharmacy shall have on site, as a minimum, one current reference from each of the following categories, including access to current periodic updates.
	1.	The Iowa Pharmacy Law and Information Manual.
	2.	A patient information reference that includes or provides patient information in compliance with rule 657—6.14(155A).
	3.	A reference on drug interactions.
	4.	A general information reference.
	5.	A drug equivalency reference.
	6.	A reference on natural or herbal medicines.
	7.	The readily accessible telephone number of a poison control center that serves the area.
	8.	Additional references as may be necessary for the pharmacist to adequately meet the needs of the patients served.
657—15.5(124,155A) Security. The pharmacy shall be located in an area or areas that facilitate the provision of services to patients. The following conditions must be met to ensure appropriate control over drugs and chemicals in the pharmacy:
	15.5(1) Locked areas. All areas occupied by the correctional facility pharmacy or where drugs or devices are maintained or stored shall be lockable by a key, combination, or electronic device so as to prevent access by unauthorized personnel and shall be locked when unoccupied or unattended.
	15.5(2) Access when pharmacist absent. The pharmacist in charge, with the concurrence of the department, shall establish and implement policies and procedures for the security of the correctional facility pharmacy. Policies and procedures shall identify who will have access to the pharmacy when the pharmacist is absent from the facility and the procedures to be followed for obtaining drugs and chemicals during that absence.
	15.5(3) Pharmacist responsibility. Each pharmacist, while on duty, shall be responsible for the security of the prescription department. This responsibility includes provisions for effective control against theft of, diversion of, or unauthorized access to prescription drugs or devices, controlled substances, records for such drugs and devices, and patient records as provided in 657—Chapter 21 and rule 657—8.16(124,155A). Policies and procedures shall identify the minimum amount of time that a pharmacist is available at the correctional facility pharmacy.
	15.5(4) Drugs in other areas of facility. All drugs distributed from the pharmacy to other areas of the correctional facility for subsequent administration to inmates shall be kept in locked storage when not in use, with access restricted to the medication nurse or qualified designee.
657—15.6 and 15.7 Reserved.
657—15.8(124,126,155A) Drug distribution and dispensing controls. Prescription drugs may be distributed or dispensed only from the original or a properly verified medication prescription order. There shall be no transcribing of medication orders by nursing or clerical staffs except for their own records.
	15.8(1) Required information. Medication prescription orders written in inmate health records shall include the following information:
	a. 	Inmate name, identification number, and location;
	b. 	Drug name, strength, dosage form, and quantity or duration;
	c. 	Directions for use;
	d. 	Date of issue;
	e. 	Prescriber’s name or signature and office address if different from that of the correctional facility or if not on file in the correctional facility pharmacy;
	f. 	Prescriber’s DEA number for controlled substances if not on file in the correctional facility pharmacy.
	15.8(2) Original maintained. The original medication prescription order and the medication administration record shall be maintained for a minimum of two years in the inmate’s health record.
	15.8(3) Effect upon transfer of inmate. Current medication prescription orders remain in effect when an inmate is transferred within the correctional institution system.
	15.8(4) Unit dose dispensing. Drugs dispensed in a unit dose dispensing system for subsequent administration by nurses or other qualified individuals shall be packaged and labeled in compliance with the provisions of rule 657—22.1(155A).
	15.8(5) Drug administration. Registered nurses may issue an inmate’s prepackaged drugs from the supply distributed by the pharmacist for that inmate into envelopes or other appropriate containers to facilitate subsequent administration by qualified individuals. Said qualified individuals shall use the medication administration record, or a properly verified copy thereof, to administer and document administration of those drugs to the inmate. The single unit or unit dose packaging shall remain intact to the point of administration.
	15.8(6) Dispensing for inmate self-administration. Drugs dispensed for self-administration by an inmate, either during the inmate’s incarceration or subsequent to the inmate’s departure from department custody status, shall be packaged and labeled in accordance with rule 657—6.10(155A).
	15.8(7) Drug product selection. Correctional facility pharmacies shall be exempt from the patient notification requirements of Iowa Code section 155A.32 when exercising drug product selection.
	15.8(8) Provisional stock. Provisional stock of prescription drugs may be supplied for use by authorized personnel pursuant to 657—22.7(124,155A). A record shall be made of all withdrawals from provisional stock. The original or properly verified copy of the emergency medication prescription order shall be left with the withdrawal record. The withdrawal record shall include the following information:
	a. 	Inmate’s name and identification number;
	b. 	Prescriber;
	c. 	Name, strength, dosage form, and quantity of the drug withdrawn;
	d. 	Signature, unique identification, or initials of the authorized person making the withdrawal;
	e. 	Date and time of administration;
	f. 	Quantity administered, if different from the quantity withdrawn;
	g. 	Signature, unique identification, or initials of the authorized person administering the drug;
	h. 	Returns to the pharmacy, including quantity returned;
	i. 	Waste, which shall be witnessed and cosigned by another licensed health care professional.
657—15.9 Reserved.
657—15.10(124,126,155A) Policies and procedures. The pharmacist in charge shall develop and implement written policies and procedures for the pharmacy drug distribution system consistent with board rules and department policies and procedures pertaining to pharmaceutical services. Policies and procedures shall address, but not be limited to, the following:
	1.	Controlled substances;
	2.	Formulary or drug list;
	3.	Stop orders;
	4.	Drug sample use and distribution;
	5.	Drug recalls;
	6.	Outdated drugs;
	7.	Patient records;
	8.	Inspection of drug inventories;
	9.	Adverse reaction reports;
	10.	Furlough or discharge medications;
	11.	Provisional stocks of drugs;
	12.	Drugs brought into the facility;
	13.	Medication administration and records;
	14.	Drug compounding;
	15.	Sterile products;
	16.	Access to the pharmacy in the absence of the pharmacist;
	17.	Transfers of drugs between facilities.
These rules are intended to implement Iowa Code sections 124.301, 124.303, 124.306, 124.308, 126.10, 126.11, 155A.13, 155A.27, 155A.28, 155A.31, 155A.32, and 155A.34 through 155A.36.
[Filed 8/26/88, Notice 6/29/88—published 9/21/88, effective 10/26/88]
[Filed emergency 5/16/89—published 6/14/89, effective 5/17/89]
[Filed 9/12/89, Notice 6/14/89—published 10/4/89, effective 11/8/89]
[Filed emergency 5/10/91—published 5/29/91, effective 5/10/91]
[Filed 7/30/91, Notice 5/29/91—published 8/21/91, effective 9/25/91]
[Filed 6/24/94, Notice 4/13/94—published 7/20/94, effective 8/24/94]
[Filed 2/27/97, Notice 1/1/97—published 3/26/97, effective 4/30/97]
[Filed 4/24/98, Notice 3/11/98—published 5/20/98, effective 6/24/98]
[Filed 2/22/99, Notice 10/21/98—published 3/10/99, effective 4/14/99]
[Filed 4/22/99, Notice 3/10/99—published 5/19/99, effective 6/23/99]
[Filed 9/8/99, Notice 6/2/99—published 10/6/99, effective 11/10/99]
[Filed 2/7/01, Notice 10/18/00—published 3/7/01, effective 4/11/01]
[Filed 8/14/02, Notice 6/12/02—published 9/4/02, effective 10/9/02]
[Filed 6/2/05, Notice 3/16/05—published 6/22/05, effective 7/27/05]
[Filed 2/7/07, Notice 10/25/06—published 2/28/07, effective 4/4/07]